RESPIKAST 4 montelukast (as sodium) 4 mg chewable tablet blister pack

Main information

  • Trade name:
  • RESPIKAST 4 montelukast (as sodium) 4 mg chewable tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RESPIKAST 4 montelukast (as sodium) 4 mg chewable tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 189243
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

189243

RESPIKAST 4 montelukast (as sodium) 4 mg chewable tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Torrent Australasia Pty Ltd

Postal Address

Coleman & Greig L9/10 George St,PARRAMATTA, NSW, 2150

Australia

ARTG Start Date

1/08/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. RESPIKAST 4 montelukast (as sodium) 4 mg chewable tablet blister pack

Product Type

Single Medicine Product

Effective date

26/03/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. Symptomatic treatment of seasonal allergic rhinitis.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

36 Months

Store below 30

degrees Celsius

Not recorded

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

28 tablets

(S4) Prescription Only Medicine

Components

1. RESPIKAST 4 montelukast sodium 4 mg tablet blister pack

Dosage Form

Tablet, chewable

Route of Administration

Oral

Visual Identification

pink coloured, oval biconvex shaped, uncoated tablets with score line on

both sides

Active Ingredients

montelukast sodium

4.16 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 12:30:46 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

RESPIKAST

MONTELUKAST (AS SODIUM) CHEWABLE TABLETS 4 mg

MONTELUKAST (AS SODIUM) CHEWABLE TABLETS 5 mg

MONTELUKAST (AS SODIUM) TABLETS 10 mg

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Respikast. It does not contain all the

available information.

It does not take the place of talking to your doctor or pharmacist. All medicines have risks and

benefits. Your doctor has weighed the risks of you taking Respikast against the benefits they

expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this

leaflet with the medicine.

You may need to read it again.

What Respikast is used for

Respikast is used to prevent asthma symptoms, including those that occur during the day and

at night-time. It also prevents the narrowing of airways triggered by exercise. If you have

seasonal allergic rhinitis (hay fever), Respikast also treats your allergic rhinitis symptoms. It

can be used in children 2 years of age and older, teenagers and adults.

Respikast tablets are not used to treat an acute attack of asthma. If an acute attack occurs,

follow your doctor's instructions for your reliever medicine, and keep taking your Respikast

each night or as prescribed.

As a preventive medicine for asthma, Respikast can be used alone or in combination with other

preventive medicines, such as inhaled corticosteroids. Your doctor may reduce your dose of

inhaled corticosteroid while you are taking Respikast .

Asthma is a lung disease and has the following characteristics:

narrowed airways causing breathing to become difficult

inflamed airways, which means the lining of airways become swollen

sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air.

Symptoms of asthma include coughing, wheezing and chest tightness. Not all people with

asthma wheeze. For some, coughing may be the only symptom of asthma. Symptoms often

occur during the night or after exercise.

For further information about asthma, contact the Asthma Foundation in your state on 1800

645 130, or www.asthmaaustralia.org.au

Seasonal allergic rhinitis (also known as hay fever) is an allergic response often caused by

airborne pollens from trees, grasses, and weeds. The daytime and night time symptoms of

seasonal allergic rhinitis typically may include: stuffy, runny, itchy nose; sneezing; watery,

swollen, red, itchy eyes

How Respikast works

Respikast is in a class of medications called leukotriene receptor antagonists (LTRAs). It

works by blocking substances in your lungs called leukotrienes that cause narrowing and

swelling of airways. Blocking leukotrienes improves asthma symptoms and helps prevent

asthma attacks.

Leukotrienes also cause allergic rhinitis symptoms. By blocking leukotrienes, Respikast

improves seasonal allergic rhinitis symptoms.

Your doctor may have prescribed Respikast for another reason. Ask your doctor if you have

any questions about why Respikast has been prescribed for you.

Respikast is not addictive.

Before you take Respikast

When you must not take it

Do not take Respikast if:

you have an allergy to Respikast or any of the ingredients listed at the end of this leaflet

the packaging is torn or shows signs of tampering

the expiry date on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start taking Respikast, talk to your doctor.

Do not give Respikast to children under 2 years of age.

Safety and effectiveness in children younger than 2 years of age have not been studied.

In studies investigating the effect of Respikast on the growth rate of children, it was shown that

Respikast did not affect the growth rate of children when given for up to 56 weeks in one

study.

Before you start to take it

Tell your doctor if:

1. you are pregnant or intend to become pregnant

Respikast has not been studied in pregnant women.

2. you are breast-feeding or plan to breastfeed

It is not known if Respikast passes into breast milk.

3. you have or have had any medical conditions

4. your child has a condition called phenylketonuria

The tablets contain aspartame (a source of phenylalanine)

5. you have any allergies to any

other medicines or any other substances, such as

foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell them before you take any

Respikast.

Taking other medicines

Some medicines may affect how Respikast works, or Respikast may affect how your

other medicines work.

Tell your doctor if you are taking any other medicines, including medicines that you buy

without a prescription from your pharmacy, supermarket or health food shop.

How to take Respikast

How much to take

For patients with asthma and/or seasonal allergic rhinitis, take Respikast only when

prescribed by your doctor.

For adults and teenagers 15 years of age and older: one 10-mg tablet.

For paediatric patients 6 to 14 years of age: one 5-mg tablet.

For paediatric patients 2 to 5 years of age: one 4-mg tablet

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for

help.

How to take it

Respikast comes as three types of tablets:

10 mg tablets for adults and teenagers 15 years and older.

5 mg chewable tablets for children 6-14 years old.

4 mg chewable tablets for children 2-5 years old.

Swallow the 10 mg tablet with a glass of water.

Chew the 5 mg or 4 mg chewable tablets thoroughly and swallow.

When to take it

Asthma:

Take your Respikast at bedtime each day.

Taking your tablet at bedtime each day is expected to have the best effect. It will also help

you remember when to take the tablets.

Seasonal allergic rhinitis:

Take your Respikast once a day as prescribed by your doctor.

Your doctor will advise you on the best time of the day to take your tablet.

Asthma and seasonal allergic rhinitis:

Take your Respikast at bedtime each day if you have both asthma and seasonal allergic

rhinitis.

It does not matter if you take Respikast before or after food.

How long to take it

Respikast helps control your asthma.

Therefore Respikast must be taken every day.

Continue taking Respikast for as long as your doctor prescribes.

If you forget to take it

Skip the dose you missed and take your next dose as usual.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering to take your tablets, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for

advice, if you think that you or anyone else may have taken too much Respikast . Do this even

if there are no signs of discomfort or poisoning.

The most common symptoms reported with overdose in adults and children include thirst,

sleepiness, dilated pupils, hyperactivity, and stomach pain.

While you are using Respikast

Things you must do

Continue taking Respikast every day as directed by your doctor, even if you have no asthma

symptoms or if you have an asthma attack.

If your asthma gets worse while taking Respikast, tell your doctor immediately.

If an acute attack of asthma occurs, follow your doctor's instructions on what reliever medicine

to use to relieve the attack.

If you become pregnant while taking Respikast, tell your doctor immediately.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you

are taking Respikast.

Things you must not do

If you have been prescribed the 10 mg tablets, do not take two 5 mg chewable tablets in its

place. If you have been prescribed the 5 mg tablets, do not take half a 10 mg tablet in its place.

The different strength tablets may not have the same effect, as they are absorbed slightly

differently in the body.

Do not take Respikast to relieve an acute asthma attack. In case of an acute asthma attack,

follow your doctor's instructions on what reliever medicine to use.

Do not give Respikast to anyone else, even if they have the same condition as you.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are

taking Respikast.

Respikast helps most people with asthma and/or seasonal allergic rhinitis, but it may have

unwanted side effects in a few people. All medicines can have side effects. Sometimes they are

serious, most of the time they are not. You may need medical treatment if you get some of the

side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

fluid retention

nose bleed

headache, dizziness, drowsiness

feeling unusually weak or tired

upper respiratory tract infection

muscle or nerve problems:

muscle aches or cramps, joint pain

decreased feeling or sensitivity, especially in the skin

pins and needles

stomach or bowel problems:

stomach pain

nausea, vomiting

diarrhoea

Tell your doctor if you notice any of the following behaviour and mood-related changes:

Behaviour and mood-related changes, including suicidal thoughts and actions, have been

reported in patients taking montelukast. If you or your child experience these changes while

taking montelukast, tell your doctor immediately.

You should immediately inform your doctor if you or your child start to have any:

agitation, including aggressive behaviour or hostility (such as temper tantrums in children),

tremor

irritability, restlessness, feeling anxious, depression and insomnia.

suicidal thoughts and actions, (as separate point)

anxiousness, depression (sad mood),

disorientation (inability to know correct time, place or person),

seeing, feeling or hearing things that are not there (also called hallucinations)

dream abnormalities, difficulty sleeping

sleep walking

disturbance in attention, memory impairment (Add this as separate sentence.)

These are usually mild side effects of Respikast.

Tell your doctor immediately if you notice any of the following:

skin rash or itchiness

increased tendency to bleed, bruising

fast or irregular heartbeats, also called palpitations

symptoms of liver disease such as nausea, vomiting, loss of appetite, feeling generally

unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine

suicidal thoughts and actions

These may be serious side effects. You may need urgent medical attention. Serious side effects

are rare.

If any of the following happen, stop taking Respikast and tell your doctor immediately or

go to accident and emergency at your nearest hospital:

swelling of the face, lips, mouth, throat or tongue which may cause difficulty in

breathing or swallowing

pinkish, itchy swellings on the skin, also called hives or nettlerash

seizure

These may be serious side effects. If you have them, you may be having a serious allergic

reaction to Respikast. You may need urgent medical attention. These side effects are rare.

Other side effects not listed above may also occur in some patients. Tell your doctor if you

notice any other effects.

After using Respikast

Storage

Keep your tablets in the blister pack until it is time to take them.

If you take the tablets out the blister pack they may not keep well.

Keep Respikast in a cool dry place, away from light, where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop taking the tablets, or the tablets have passed their expiry date,

ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Respikast comes as three types of tablets:

10 mg tablet - Light brown colored, round biconvex shaped, uncoated tablets, with breakline

on both the sides.

5 mg chewable tablet - pink colored, round shaped, uncoated tablets, with break line on both

the sides.

4 mg chewable tablet - pink colored, oval biconvex shaped, uncoated tablets, with breakline on

both the sides.

Supplied in blister packs of 4 x 7 tablets.

Ingredients

Active ingredient:

10 mg tablet contains 10 mg montelukast

5 mg chewable tablet contains 5 mg montelukast

4 mg chewable tablet contains 4 mg montelukast

Inactive ingredients:

1. 10 mg tablets:

mannitol,

microcrystalline cellulose, croscarmellose sodium, iron oxide red,

iron oxide yellow, cherry flavour, aspartame and magnesium stearate

2. 5 mg and 4 mg chewable tablets:

mannitol, microcrystalline cellulose, iron oxide red,

croscarmellose sodium, cherry flavour, aspartame, and magnesium stearate

Supplier

Torrent Australasia Pty Ltd

Level 9/10 George Street,

Parramatta NSW 2150

Australia

This leaflet was prepared in February 2019

AUST R Numbers:

10 mg tablets: AUST R 189243

5 mg tablets: AUST R 189230

4 mg tablets: AUST R 189221